What does risk management entail?
Risk management encompasses many areas:
Threat modeling: MDIC/MITRE Threat Modeling Playbook
Cybersecurity risk assessment: Postmarket Cybersecurity Guidance
Controls
SBOM and supporting info: NITA SBOM Framing Document
Testing: FDA Recognized standards AAMI/UL 2900-1:2017, Clauses 13-19 or IEC 81001-5-1: 2021, Clauses 5.5-5.7
Unresolved anomalies: Premarket Software Guidance
Traceability
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